best in class - dekas vitamins · 2020. 4. 2. · mineral supplement that contains higher amounts...

Developed with grants from the US CF Foundation & NIH

Best in ClassComplete Multivitamin & MineralSupplement for use in Cystic Fibrosis

* DEKAs is a registered trademark of Callion Pharma.

IMPORTANT NOTICEDEKAs* is a Food for Special Medical Purposes, for the dietary management of patients with

Cystic Fibrosis on the specific recommendation of a Cystic Fibrosis specialist. Use only under medical supervision. Please read product information on the inside.

DEKAs Plus liquid

DEKAs Essential capsules DEKAs Plus softgels

DEKAs Plus chewables

CLINICALLYTESTED DELIVERYTECHNOLOGY

DEKAs nutritional information

ProductDEKAs

Plus softgels

DEKAsPlus

chewables

DEKAs Essential capsules

DEKAsPlus

liquid

One pack contains 60 softgels

60chewables

60 capsules

60 ml liquid

1 softgel 1 chewable 1 capsule 1 ml 2ml

Vitamin A as retinyl palmitate

IU (μg RE)* 1500 (450) 1500 (450) 500 (150) 750 (225) 1500 (450)

Vitamin A as ß-carotene

IU (mg RE)* 16667 (10) 16667 (10) 1500 (0,9) 5001 (3) 10002 (6)

Vitamin D3 IU (μg) 3000 (75) 2000 (50) 2000 (50) 750 (18,8) 1500 (37,5)

Vitamin E IU (mg) 150 (101) 100 (67,2) 150 (101) 50 (33,6) 100 (67,2)

Vitamin K1 μg 1000 1000 1000 500 1000

Thiamin (B1) mg 1,5 1,5 0,6 1,2

Riboflavin (B2) mg 1,7 1,7 0,6 1,2

Niacin mg 10 10 6 12

Vitamin B6 mg 1,9 1,9 0,6 1,2

Folic acid μg 200 200 -

Vitamin B12 μg 12 12 -

Vitamin C mg 75 75 45 90

Biotin μg 100 100 15 30

Pantothenic Acid mg 12 12 3 6

Zinc mg 10 10 5 10

Selenium μg 75 75 10 20

Co-enzyme Q10 mg 10 10 2 4

* RE = all trans retinol equivalent. ß-carotene is a precursor to vitamin A, and is converted by the body to vitamin A as needed.

Choose Best in Class. Choose DEKAs

1. Sermet-Gaudelus I, et al., European cystic fibrosis bone mineralisation guidelines. J Cyst Fibros 2011;10(2):S16-23.2. Turck D, et al., ESPEN-ESPGHAN-ECFS guidelines on nutrition care for infants, children, and adults with cystic fibrosis,

Clinical Nutrition (2016), http://dx.doi.org/10.1016/j.clnu.2016.03.004

DEKAs enables you to comply with the latest European Cystic Fibrosis Guidelines1,2

Why is DEKAs best in its class?Attribute DEKAs Alternatives

Absorption technology Proven in clinical trials in CF and cholestasis1,4

No or based on in-vitro models

Taste masking technology Yes Rarely

Clinical studies in CF Yes, 7 studies1,4 No

Rich in zinc, selenium, vitamin C, β-carotene, mixed tocopherols

Yes, rich in antioxidants with proven clinical benefits in CF2,3

Variable

Choice of Forms Liquid, softgels, chewables, capsules

1 form per age group

Formulation Water-based liquid Oil-based liquid

Avoids high vitamin A Yes. Vitamin A is given mostly as beta-carotene, not retinol.

No. Often vitamin A is given as retinol only.

Pregnancy Avoids low/high vitamin A levels.

High vitamin A levels often possible.

Dose of Vitamin K1/day 0,5 – 2 mg, shown to be sufficient in clinical studies e.g. with DEKAs formulations4.

Usually lower or higher (5-10 mg), without clinical studies to justify these low or very high doses in CF.

Average cost per day DEKAs is 100% reimbursed. Internet: priced competitively

Variable. Some products are low on expensive ingredients.

Choose Best in Class. Choose DEKAs

1. All studies were done with the DEKAs/AquADEKs formulation with its specific absorption technology. Doses of vitamin D and K were lower in the formulations used in the initial studies and later adapted to guideline compliant levels.

2. Sagel SD, et al. Effects of an antioxidant-enriched multivitamin in cystic fibrosis. Am J Respir Crit Care Med (2018) Sep 1;198(5):639-647.

3. Renner, S, et al. Effects of beta-carotene supplementation for six months on clinical and laboratory parameters in patients with cystic fibrosis. Thorax 2001; 56: 48-52.

4. Please ask us for a full bibliography and evidence review on [email protected]

DEKAs prescribing information1

DEKAs enables you to comply with the latest European Cystic Fibrosis Guidelines3,4

DEKAs availability

Product Initial daily dose2 For higher dosing

DEKAs Plus softgels – 60 softgels 1-2 Add DEKAs Essential capsule(s)

DEKAs Plus chewable tablets – 60 tabs 1 -2 Add DEKAs Essential capsule(s)

DEKAs Plus liquid – 60 ml 1-2 ml Consider solid forms

DEKAs Essential capsules – 60 caps 1-2

1. Also see attached Product Information2. Depending on patient age and vitamin doses needed previously by the patient3. Sermet-Gaudelus I, et al., European cystic fibrosis bone mineralisation guidelines. J Cyst Fibros 2011;10(2):S16-23. 4. Turck D, et al., ESPEN-ESPGHAN-ECFS guidelines on nutrition care for infants, children, and adults with cystic fibrosis,

Clinical Nutrition (2016), http://dx.doi.org/10.1016/j.clnu.2016.03.004

WebshopVisit www.DEKAsvitamins.com. Available in English, German, French or Spanish. The shop ships to over 60 countries. Free shipping as of 2-5 packs depending on destination. Prices from €0,65 per day depending on dose, product, country and quantity ordered.

Benelux Available via wholesalers and pharmacies. For the Benelux please contact: Roberto Jongejan MD, Head of EU [email protected]

+31 6 21255794

France and other European CountriesAvailable soon via wholesalers and pharmacies. Please contact: Roberto Jongejan MD, Head of EU [email protected]

+31 6 21255794

Germany and AustriaIn Austria DEKAs is available via wholesalers and pharmacies. For Germany please contact:Dirk Krause MD, Country [email protected]

0174 4440440

ItalyWill be available via wholesalers and pharmacies. For Italy please contact:PIAM Farmaceutici S.P.A., [email protected]

010518621

SpainDirect to CF centres. Will be available via wholesalers and pharmacies. For Spain please contact: Roberto Jongejan MD, Head of EU [email protected]

+31 6 21255794

SwitzerlandApotheke zum Rebstock, Stä[email protected]

043-477 22 44

UKAvailable via wholesaler and pharmacies. For the UK please contact: Simon Deck, Country [email protected]

07879 427173

Version 1 - 1 January 2020

Product information: DEKAs Plus liquid, food for special medical purposes. For the dietary management of patients with cystic fibrosis on the specific recommendation of a specialist in cystic fibrosis. DEKAs Plus is a multivitamin and mineral supplement that contains higher amounts of fat-soluble vitamins. DEKAs Plus utilizes a clinically tested delivery technology to enhance absorptionof fat-soluble vitamins and nutrients. Important notice: For children from 0-3 years of age. Use only under medical supervision. Not for parenteral use. Cannot be used as a sole source of nutrition. The product poses a health hazard if consumed by persons who do not have the disease (s), disorder(s) or medical conditions for which the product is intended. Use during pregnancy and/or combined use with anticoagulants only after consultation with a doctor. Use and storage: Do not use if the seal is broken or missing. Shake well before use. Keep out of reach of children. Store at room temperature. Refrigerate after opening. Recommended dosage: Age 0 to 12 months: 1 ml daily. Age 1-3 years: 2ml daily. Or as directed by physician. Allergens: none.

Ingredients: water, L-ascorbic acid, sodium-L- ascorbate, D-alpha- tocopheryl polyethylene glycol-1000 succinate, zinc gluconate, beta-carotene, D-alpha-tocopherol, antioxidant (tocopherol-rich extracts), nicotinamide, natural and artificial flavors, calcium D-pantothenate, sweetener (sucralose), coenzyme Q10, thiamin hydrochloride, riboflavin 5’- phosphate sodium, cholecalciferol, pyridoxine hydrochloride, retinyl palmitate, preservatives (potassium sorbate, sodium benzoate), phytomenadione, sodium selenite, D-biotin.

Product information: DEKAs Plus softgels, food for special medical purposes. For the dietary management of patients with cystic fibrosis on the specific recommendation of a specialist in cystic fibrosis. DEKAs Plus is a multivitamin and mineral supplement that contains higher amounts of fat-soluble vitamins. DEKAs Plus utilizes a clinically tested delivery technology to enhance absorption of fatsoluble vitamins and nutrients. Important notice: Use only under medical supervision. Cannot be used as a sole source of nutrition. Can be used from the age of 10 years. The product poses a health hazard if consumed by persons who do not have the disease (s), disorder(s) or medical conditions for which the product is intended. Use during pregnancy and/or combined use with anticoagulants only after consultation with a doctor. Use and storage: Do not use if the seal is broken or missing. Keep out of reach of children. Store at room temperature. Recommended dosage: Age 4 to 10 years: 1 softgel daily or as directed by physician. Over age 10: 1-2 softgels per day as directed by physician. Take with meals. Allergens: none.

Ingredients: capsule (bovine gelatin, humectants: E422, E420; colorants: E150d, E171, flavouring: ethylvanillin), soybean oil, D-alpha-tocopheryl polyethylene glycol-1000 succinate, antioxidant (tocopherol-rich extracts), sodium ascorbate, D-alpha-tocopherol, selenium enriched yeast, beta-carotene, zinc sulphate, calcium D-pantothenate, nicotinamide, D-biotin, coenzyme Q10, cholecalciferol, pyridoxine hydrochloride, thiamin mononitrate, riboflavin, cyanocobalamin, retinyl palmitate, phytomenadione, folic acid.

Nutritional informationcontains 60 ml 1 ml 100 mlEnergy kJ / kcal 4 / 1 400 / 100Fat of which

g 0 0

saturates g 0 0Carbohydratesof which

g 0,3 22

Sugars g 0 0Protein g 0,02 2Salt g 0,01 1Vitamin A as retinyl palmitate

μg RE* (IU) 225 (750) 300000 (500100)

Vitamin A as beta-carotene

μg RE* (IU) 3000 (5001) 100000 (166666)

Vitamin C mg 45 4500Vitamin D3 μg (IU) 18,8 (750) 1875 (75000)Vitamin E mg (IU) 33,6 (50) 3355 (5000)Vitamin K1 μg 500 50000Vitamin B1 - Thiamin mg 0,6 60Vitamin B2 - Riboflavin mg 0,6 60Niacin mg 6 600Vitamin B6 mg 0,6 60Biotin μg 15 1500Pantothenic Acid mg 3 300Zinc mg 5 500Selenium μg 10 1000Coenzyme Q10 mg 2 200

Nutritional informationcontains 60 softgels 1 softgel 100 gEnergy kJ / kcal 20 / 5 2090 / 500Fat of which

g 0,5 43

saturates g 0,4 36Carbohydratesof which

g 0,3 22

Sugars g <0,1 <0,1Protein g 0,3 25Salt g <0,1 1,0Vitamin A as retinyl palmitate

μg RE* (IU) 450 (1500) 37500 (125000)


μg RE* (IU) 10000 (16667) 833333 (1388917)

Vitamin C mg 75 6250Vitamin D3 μg (IU) 75 (3000) 6250 (250001)Vitamin E mg (IU) 101 (150) 8389 (12500)Vitamin K1 μg 1000 88333Vitamin B1 - Thiamin mg 1,5 125Vitamin B2 - Riboflavin mg 1,7 142Niacin mg 10 833Vitamin B6 mg 1,9 158Folic acid μg 200 16668Vitamin B12 μg 12 1000Biotin μg 100 8333Pantothenic Acid mg 12 1000Zinc mg 10 833Selenium μg 75 6250Coenzyme Q10 mg 10 833

liquidwith sweetener(s)

DEKAs Plus®PlusPlus®

®PlusPlus®

* RE = all trans retinol equivalent


Distribution

Alveolus Biomedical B.V., Platolaan 71, 3707 GD Zeist, NL. www.dekasvitamins.com

Distribution


Manufactured in the USA for

232 Presidential Drive, Suite 7Jonesborough, TN 37659 USA www.callionpharma.com



softgelsDEKAs Plus

Nutritional informationcontains 60 chewable tablets

1 chewable tablet

100 g

Energy kJ / kcal 48 / 12 1577 / 377Fat of which

g 0 1,8

saturates g 0 1,6Carbohydratesof which

g 2,7 88

Sugars g 2,1 70Protein g 0 2,5Salt g 0,01 0,42Vitamin A as retinyl palmitate

μg RE* (IU) 450 (1500) 14754 (49180)


μg RE* (IU) 10000 (16667) 327867 (546455)

Vitamin C mg 70 2295Vitamin D3 μg (IU) 50 (2000) 1639 (65574)Vitamin E mg (IU) 67 (100) 2197 (3279)Vitamin K1 μg 1000 32787Vitamin B1 - Thiamin mg 1,5 49Vitamin B2 - Riboflavin mg 1,7 56Niacin mg 10 328Vitamin B6 mg 1,9 62Folic acid μg 200 6557Vitamin B12 μg 12 393Biotin μg 100 3279Pantothenic Acid mg 12 393Zinc mg 10 328Selenium μg 75 2459Coenzyme Q10 mg 10 328

Product information: DEKAs Plus chewable tablets, food for special medical purposes. For the dietary management of patients with cystic fibrosis on the specific recommendation of a specialist in cystic fibrosis. DEKAs Plus is a multivitamin and mineral supplement that contains higher amounts of fat-soluble vitamins. DEKAs Plus utilizes a clinically tested delivery technology to enhance absorption of fat-soluble vitamins and nutrients. Important notice: Use only under medical supervision. Cannot be used as a sole source of nutrition. Can be used from the age of 4 years. The product poses a health hazard if consumed by persons who do not have the disease(s), disorder(s) or medical conditions for which the product is intended. Use during pregnancy and/or combined use with anticoagulants only after consultation with a doctor. Use and storage: Do not use if the seal is broken or missing. Keep out of reach of children. Store at room temperature. Recommended dosage: Age 4 to 10 years: 1 chewable tablet daily or as directed by physician. Over age 10: 1-2 chewable tablets per day as directed by a physician. Take with meals. Allergens: none.

Ingredients: sugar, dextrose, natural flavors, sodium-L-ascorbate, sweetener (sorbitol), bulking agent (hydroxypropylcellulose), beta-carotene, D-alphatocopherol, anti-caking agent (calcium silicate), flavor (citric acid), zinc bisglycinate, nicotinamide, cholecalciferol, phytomenadione, D-alpha-tocopheryl polyethylene glycol-1000 succinate (TPGS), calcium D-pantothenate, anti-caking agent (magnesium stearate), D-biotin, coenzyme Q10, pyridoxine hydrochloride, retinyl palmitate, sodium selenite, thiamin mononitrate, riboflavin, sweetener (sucralose), anti-caking agent (silicon dioxide), cyanocobalamin, antioxidant (mixed tocopherols), folic acid.

Product information: DEKAs Essential capsules, food for special medical purposes. For the dietary management of patients with cystic fibrosis on the specific recommendation of a specialist in cystic fibrosis. DEKAs Essential capsules are a multivitamin supplement that contain higher amounts of fat-soluble vitamins. DEKAs Essential capsules utilize a clinically tested delivery technology to enhance absorption of fat-soluble vitamins and nutrients. Important notice: Use only under medical supervision. Cannot be used as a sole source of nutrition. Can be used from the age of 4 years. The product poses a health hazard if consumed by persons who do not have the disease (s), disorder(s) or medical conditions for which the product is intended. Use during pregnancy and/or combined use with anticoagulants only after consultation with a doctor. Use and storage: Do not use if the seal is broken or missing. Keep out of reach of children. Store at room temperature. Recommended dosage: Age 4 to 10 years: 1 capsule daily or as directed by physician. Over age 10: 1-2 capsules per day as directed by a physician. Take with meals.

Ingredients: D-alpha-tocopheryl polyethylene glycol-1000 succinate (TPGS), D-alpha-tocopherol, capsule (tilapia fish gelatin, water), beta-carotene, cholecalciferol, phytomenadione, retinyl palmitate.

Nutritional informationcontains 60 capsules 1 capsule 100 gEnergy kJ / kcal 8 / 2 2642 / 631Fat of which

g 0 49

saturates g 0 36Carbohydratesof which

g 0 50

Sugars g 0 0Protein g 0 0Salt g 0 0Vitamin A as retinyl palmitate

μg RE* (IU) 150 (500) 55350 (184500)


μg RE* (IU) 900 (1500) 332100 (553500)

Vitamin D3 μg (IU) 50 (2000) 18450 (738000)Vitamin E mg (IU) 101 (150) 37269 (55350)Vitamin K1 μg 1000 369000

®PlusPlus®

®EssentialEssential®



Distribution


Distribution






chewable tabletswith sugar(s) and sweetener(s)

DEKAs Plus

capsulesDEKAs Essential

best in class - dekas vitamins · 2020. 4. 2. · mineral supplement that contains higher amounts...

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